To evaluate if patients with chronic, recurrent lateral ankle instability who are treated with surgical lateral ankle ligament repair protected with an internal brace, have significant better ankle function after surgery compared to patients treated…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in FAOS score three months after surgery between the
Intervention Group and the Control Group is the main study endpoint.
Secondary outcome
Secondary endpoints are the incidence of recurrent ankle inversion trauma
within one year after surgery and differences in subjective and objective ankle
stability, motor control, pain, ankle function and satisfaction with the
treatment between the IG and the CG. This will be determined by means of
questionnaires, physical examination and clinimetric testing.
Background summary
Ankle inversion trauma often leads to chronic ankle instability which can
severely limit the patient during daily activities, including work and sports.
When conservative treatment fails, surgical treatment in which the ruptured
anterior talofibular ligament (ATFL) is reconstructed can be considered.
Surgical treatment for ankle instability is associated with a relatively long
rehabilitation due to the initial limited strength of the reconstructed
ligament. This limited strength in the first weeks after surgery makes it
necessary to protect the reconstructed lateral ankle ligament with
immobilization. Usually a lower leg plaster is applied for six weeks. Due to
the initial limited strength of the reconstructed ligament and the
immobilization period itself, return to activities after surgery for this
injury usually takes up to six months or even more. Therefore, surgical
intervention is only indicated for patients who suffer chronic, recurrent ankle
instability.
With a new surgical technique, an internal brace is placed over the
reconstructed lateral ankle ligament, thereby providing protection which makes
immobilization in the postoperative weeks unnecessary. This allows an earlier
start of the rehabilitation which in theory should result in patients being
able to return to activities earlier after surgery. Also, adding an internal
brace to the reconstructed lateral ankle ligament might result in a lower
recurrence rate of ankle instability compared to the current surgical
procedure.
Study objective
To evaluate if patients with chronic, recurrent lateral ankle instability who
are treated with surgical lateral ankle ligament repair protected with an
internal brace, have significant better ankle function after surgery compared
to patients treated with standard surgical lateral ankle ligament
reconstruction without internal brace. The appropriately adapted rehabilitation
for each surgery procedure is applied.
Study design
Multicenter randomized controlled trial (RCT).
Intervention
The Intervention Group (IG) has surgery to reconstruct the anterior talofibular
ligament with an internal brace placed over the reconstructed ligament in the
same surgical session. After surgery patients will receive physiotherapy
treatment using an accelerated rehabilitation protocol. The Control Group (CG)
receives the same operative treatment but without internal brace. After a six
week immobilization period they will receive physiotherapy treatment in
accordance with current national guidelines.
Study burden and risks
Both groups will undergo surgical treatment. Patients will be admitted to the
hospital on the day of the surgery, and they will be discharged the same day or
the following morning if no complications occur. Patients in the Intervention
Group start physiotherapy within one week after surgery and will have a follow
up visit at 2, 6 and 12 weeks and at 6 and 12 months after the surgery.
Potential risks and complications of all surgery procedures include swelling,
infection, pain, wound dehiscence and nerve damage. Standard hospital protocols
will be applied to minimize these risks. Specific risks and complications
associated with placing the internal brace are overtightening of the internal
brace resulting in limited ankle range of motion and premature loosening of the
internal brace thereby no longer protecting the ankle ligament reconstruction.
Both groups will complete questionnaires before treatment and at 6 and 12
weeks, and at 6, 9 and 12 months follow up. Expected benefits from study
participation are that the rehabilitation is extra controlled on conductance in
accordance with current National guidelines (control group), and for the
intervention group we expect a quicker return to physical activity and a lower
recurrence rate of ankle inversion trauma. Furthermore by participating in the
study the patient will receive more follow up moments compared to standard
treatment, which might possibly lead to earlier detection of delayed recovery.
Bogardeind 2
Geldrop 5664 EH
NL
Bogardeind 2
Geldrop 5664 EH
NL
Listed location countries
Age
Inclusion criteria
- Male or female patient diagnosed with chronic lateral ankle instability
(multiple ankle inversion trauma within 12 months and symptoms present >1
year). Lateral ankle instability is present if the patient complains of giving
way of the ankle and has positive signs of ankle instability during physical
exam (talar tilt score of >15 degrees compared to contralateral ankle or
anterior drawer test score of >10mm compared to the contralateral ankle.
- Conservative therapy has failed.
- Normal foot and ankle anatomy as determined by orthopedic surgeon.
- Patients in whom their ankle symptoms interfere with their physical
activities.
- Patients between the age of 18 and 60 years.
- Patients with isolated anterior talofibular ligament which is indicated for
repair using the Brostrom-Gould technique.
- BMI <=30
- Patients who are able and willing to undergo ankle surgery.
- Patients who are able and willing to comply with the rehabilitation protocol
in any of the study physiotherapy centers.
- Patients who are able and willing to return for follow-up evaluations.
- Patients with sufficient understanding of the Dutch language.
Exclusion criteria
- Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament
reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc).
- Patients with comorbidities, including musculoskeletal injuries or diseases
in other joints than the affected ankle which limits their physical activity.
- Ankle instability due to abnormal foot and ankle anatomy.
- No objective or subjective ankle instability.
- Previous ankle surgery.
- Patients in which the contralateral ankle also shows lateral ankle
instability.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64224.015.17 |